ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung
About this role
- Conduct audits and assessments in accordance with ISO13485, MDSAP, MDR based on the directive, regulation, harmonized standards and other applicable regulatory requirement following DNV’s accredited certification program and procedure.
- Ensure independent and ethical of all auditing activities, upholding DNV’s values of integrity and impartiality.
- Contribute to continuous improvement efforts by identifying and driving enhancements in audit processes, information management, and service delivery across teams.
- Plan and deliver client projects such as assessments, gap analyses, training workshops, and other consultancy activities as assigned.
- Maintain qualification and registration as a Lead Auditor/Assessor with DNV and relevant regulatory authorities.
- Perform additional duties as assigned by the line manager to support team and business objectives.
- Flexible work arrangements for better work-life balance
- Generous Paid Leaves (Annual Paid Leave, Sick Leave)
- Medical benefits (Standard medical check-up)
- Pension and Insurance Policies
- Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme)
- Additional Benefits (Long Service Awards, Mobile Phone Reimbursement, Professional Membership Fees)
*Benefits may vary based on position, tenure/contract/grade level*
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.
- Relevant Bachelor or higher degree related to medical science and medical device area. Core disciplines: biology or microbiology; biomechanical engineering; chemistry or biochemistry, medicine and clinic practice; computer and software technology; electrical, electronic, mechanical or bioengineering. etc.
- Minimum 4 years of hands-on experience in the design, manufacturing, testing, or clinical use of medical devices within industry, laboratory, or hospital environments. Prefer product group: MDN1206 non-active ophthalmologic device, MDN1201 non-active deice for anesthesia, emergency and intensive care, MDN1202 non-active device for administration, channelling and removal od substances, including dialysis.
- High customer focus and service orientation
- Strong communication and interpersonal skills
- Proven ability to work collaboratively in teams and across functions
- Self-motivated with strong commitment to continuous learning and development
- Fluency in both written and spoken English is required
Security and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices.
Frequently Asked Questions
Is the salary disclosed for the ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung position at DNV?
The salary for this ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung role at DNV is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung position at DNV located?
This ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung role at DNV is based in Kaohsiung, China, Taipei, China. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung role at DNV full-time or part-time?
This is listed as a Full time position. It is posted as a ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung role at DNV.
How do I apply for the ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung position at DNV?
Click the "Apply Now" button on this page. You will be redirected to DNV's official application portal hosted on oraclecloud where you can submit your application directly.
When was the ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung job at DNV posted?
This ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung position at DNV was posted on Sep 16, 2026. Apply as soon as possible — early applications are often reviewed first.
ISO13485 & MDR Auditor/Assessor-Taipei/ Kaohsiung
DNV
You'll be redirected to DNV's official application page on oraclecloud.